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Barriers for conducting clinical trials in developing countries- a systematic review

BACKGROUND: Clinical trials for identification of efficient and effective new diagnostic and treatment modalities are needed to address disproportionately high burden of communicable (e.g., HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (e.g., diabetes) in developing countries. H...

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Autores principales: Alemayehu, Chalachew, Mitchell, Geoffrey, Nikles, Jane
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5863824/
https://www.ncbi.nlm.nih.gov/pubmed/29566721
http://dx.doi.org/10.1186/s12939-018-0748-6
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author Alemayehu, Chalachew
Mitchell, Geoffrey
Nikles, Jane
author_facet Alemayehu, Chalachew
Mitchell, Geoffrey
Nikles, Jane
author_sort Alemayehu, Chalachew
collection PubMed
description BACKGROUND: Clinical trials for identification of efficient and effective new diagnostic and treatment modalities are needed to address disproportionately high burden of communicable (e.g., HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (e.g., diabetes) in developing countries. However, gross under-representation in global clinical trial platforms contributes to sustained health inequity in these countries. We reviewed the literature on barriers facing clinical researchers in developing countries for conducting clinical trials in their countries. METHODS: Literature indexed in PubMed, Embase, CINAHL and Web of Science, WHO Global Health Library were searched. Grey literature was also searched. Search key words included barriers, challenges, clinical trials and developing countries. Articles within the scope of this review were appraised by two reviewers. RESULTS: Ten studies, which are reported in 15 papers, were included in this review. Following critical review we identified five unifying themes for barriers. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands. CONCLUSION AND RECOMMENDATION: There were substantial barriers at system, organization and individual level. We propose that to address this problem, instituting a system for wider implementation of local investigator-initiated trials is warranted. These trials are more applicable to local populations because they build on local healthcare knowledge. They are more demand-led, influence policy and responsive to a country’s needs because they are driven by a local or national agenda. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12939-018-0748-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-58638242018-03-27 Barriers for conducting clinical trials in developing countries- a systematic review Alemayehu, Chalachew Mitchell, Geoffrey Nikles, Jane Int J Equity Health Systematic Review BACKGROUND: Clinical trials for identification of efficient and effective new diagnostic and treatment modalities are needed to address disproportionately high burden of communicable (e.g., HIV/AIDS, tuberculosis, and malaria) and non-communicable diseases (e.g., diabetes) in developing countries. However, gross under-representation in global clinical trial platforms contributes to sustained health inequity in these countries. We reviewed the literature on barriers facing clinical researchers in developing countries for conducting clinical trials in their countries. METHODS: Literature indexed in PubMed, Embase, CINAHL and Web of Science, WHO Global Health Library were searched. Grey literature was also searched. Search key words included barriers, challenges, clinical trials and developing countries. Articles within the scope of this review were appraised by two reviewers. RESULTS: Ten studies, which are reported in 15 papers, were included in this review. Following critical review we identified five unifying themes for barriers. Barriers for conducting clinical trials included lack of financial and human capacity, ethical and regulatory system obstacles, lack of research environment, operational barriers and competing demands. CONCLUSION AND RECOMMENDATION: There were substantial barriers at system, organization and individual level. We propose that to address this problem, instituting a system for wider implementation of local investigator-initiated trials is warranted. These trials are more applicable to local populations because they build on local healthcare knowledge. They are more demand-led, influence policy and responsive to a country’s needs because they are driven by a local or national agenda. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12939-018-0748-6) contains supplementary material, which is available to authorized users. BioMed Central 2018-03-22 /pmc/articles/PMC5863824/ /pubmed/29566721 http://dx.doi.org/10.1186/s12939-018-0748-6 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Systematic Review
Alemayehu, Chalachew
Mitchell, Geoffrey
Nikles, Jane
Barriers for conducting clinical trials in developing countries- a systematic review
title Barriers for conducting clinical trials in developing countries- a systematic review
title_full Barriers for conducting clinical trials in developing countries- a systematic review
title_fullStr Barriers for conducting clinical trials in developing countries- a systematic review
title_full_unstemmed Barriers for conducting clinical trials in developing countries- a systematic review
title_short Barriers for conducting clinical trials in developing countries- a systematic review
title_sort barriers for conducting clinical trials in developing countries- a systematic review
topic Systematic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5863824/
https://www.ncbi.nlm.nih.gov/pubmed/29566721
http://dx.doi.org/10.1186/s12939-018-0748-6
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